Atlas FDA

Cerasorb Ortho Foam

FDA 510(k) clearance K160566 · decided 2016-12-02

Clearance details

K-number
K160566
Device name
Cerasorb Ortho Foam
Applicant
Curasan AG
Decision
Substantially Equivalent
Date received
2016-02-29
Decision date
2016-12-02
Days to decision
277 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Kleinostheim, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CERASORB DENTAL (P800035/S011)Curasan AG2003-12-08
PERI-OSS (P800035/S010)Curasan AG2001-10-04
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S007)Curasan AG1984-08-07
AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG (P800035/S008)Curasan AG1983-11-10
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S004)Curasan AG1983-06-07
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S003)Curasan AG1982-11-08
SYNTHOGRAFT(TM) LARGE GRANULAR (LG) (P800035/S005)Curasan AG1982-08-09
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S002)Curasan AG1982-07-16